The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

Secondary Outcome Measures:

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]

Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years [ Time Frame: From day 30 to 4 years ]

Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From month 6 to 4 years ]

SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).

Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days. ]

Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment [ Time Frame: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days ]

Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

Time to First Exacerbation [ Time Frame: From Day 1 to 4 years ]

Chronic obstructive pulmonary disease (COPD) exacerbation

Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year [ Time Frame: Day 1 to 4 years ]

Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: Day 1 to 4 years ]

Number of Exacerbation Days Per Patient Year [ Time Frame: Day 1 to 4 years ]

Number of exacerbation days normalized by treatment exposure

Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) [ Time Frame: Day 1 to 4 years ]

Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]

Number of Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]

Estimated number of exacerbations leading to hospitalizations per patient year

Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization [ Time Frame: From Day 1 to 4 years ]

Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)

SGRQ total score summarizes the impact of COPD on overall patient's health status.

Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.

The scale is continuous.

Rate of decline shows the yearly change of SGRQ total score.

Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]

On-treatment defined as day 1 to completion of double blinded treatment plus 30 days

Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]

All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.

Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) [ Time Frame: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days ]

The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days

Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) [ Time Frame: Day 1 to day 1470 ]

The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used

Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.

Myocardial infarction in past 6 months.

Unstable or life threatening arrhythmia in past year.

Hospitalization for NYHA heart failure class III or IV in past year.

Active tuberculosis.

Asthma.

Pulmonary resection.

Malignancy treated with radiation or chemotherapy in past 5 years.

Respiratory infection in 4 weeks prior to screening.

Known hypersensitivity to anticholinergic drugs or components.

Known moderate to severe renal impairment.

Known narrow angle glaucoma.

Significant symptomatic BPH or bladder neck obstruction.

Need for oxygen therapy >12 hr/day.

Use of oral corticosteroids at unstable doses or >10 mg/day.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144339